Anvisa is accepted as a member of the international API Inspection Programs. With representatives from the UK, Japan, USA and WHO, among others, the program aims to streamline GMP inspections for international API manufacturers.
The National Health Surveillance Agency (ANVISA) has been accepted into the International Program for Rationalization of Good Manufacturing Practices (GMP) Inspections of Active Pharmaceutical Ingredients (APIs). With this, Brazil is now part of a group formed by several countries that work together to carry out inspections and share information.
The official communication of Anvisa’s adhesion to the API Cluster Program was made last week by the European Medicines Agency – EMA.
The membership of the program strengthens the already existing cooperation between the agencies, with the recognition of Anvisa as an active participant, contributing to the international improvement and rationalization of inspections of good manufacturing practices for active pharmaceutical ingredients.
As an effective member of the API Cluster, a greater exchange of information between regulatory agencies will be possible, with consequent improvement in the inspection capacity of the participants, allowing more sites to be monitored and reducing the duplicity of actions.
API CLUSTER PROGRAM
The program aims to streamline GMP inspections for international API manufacturers, with a focus on cooperation and mutual trust among participating regulators, facilitating communication and information exchange.
The initiative facilitates the exchange of data on inspection schedules, as well as the outcome of these activities, including the organization of joint inspections between members at manufacturing sites of common interest.
In addition to Brazil, the participating member authorities are the following (click in each button to access the agency’s website of each country):
Anvisa’s entry into the program is another step in the agency’s efforts towards international regulatory convergence, just like its recent admission into the Pharmaceutical Inspection Co-operation Scheme – PIC/S, which shows the strengthening and international recognition of the Agency’s work in the area of health inspections.
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Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, and Mexico. GRP helps many life science companies register their products in different countries in compliance with local regulations.